Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1, 3, 5, 6, 16, 20, 24, 27, 29, 32, 36, 38-40, 42, 44, 46, 52, 59 and 60 are currently pending in the instant application. Applicants have amended claims 44, 46 and 60 and canceled claims 2, 4, 7-15, 17-19, 21-23, 25-26, 28, 30-31, 33-35, 37, 41, 43, 45, 47-51 and 53-58 in an amendment filed on June 2, 2026. Claims 16, 20, 44, 46, 59 and 60 are rejected and claims 1, 3, 5, 6, 24, 27, 29, 32, 36, 38-40, 42, 52 are objected in this Office Action.
I. Priority
The instant application is a 371 of PCT/CN2022/111089, filed on August 9, 2022 and claims benefit of Foreign Applications CHINA PCT/CN2022/106648, filed on July 20, 2022 and CHINA PCT/CN2021/112521, filed on August 13, 2021.
II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 29, 2024, March 22, 2024 and June 13, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
III. Restriction/Election
A. Election: Applicant's Response
Applicants' election with traverse of Pair A in the reply filed on June 2, 2026 is acknowledged. The traversal is on the ground(s) that: (1) the common features of Markush Formula I are non-obvious over the prior art disclosed by Barron.
All of the Applicants' arguments have been considered are found persuasive. The Examiner has withdrawn the restriction requirement and has examined the full scope of the claimed invention set forth in claims 1, 3, 5, 6, 16, 20, 24, 27, 29, 32, 36, 38-40, 42, 44, 46, 52, 59 and 60.
IV. Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16, 20, 46 and 60 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claims 16 and 20, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 59 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “improving” in claim 59 is a relative term which renders the claim indefinite. The term “improving” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicants are suggested to delete claim 59 to overcome the rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 44, 46 and 60 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), because the specification, while being enabling for a method for the treatment of diseases which are modulated by PPARα and/or PPAR γ agonists does not reasonably provide enablement for a method for the prophylaxis of diseases which are modulated by PPARα and/or PPAR γ agonists. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01 (a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case
The nature of the invention
The nature of the invention is a method for the treatment of diseases which are modulated by PPARα and/or PPAR γ agonists.
Support for the intended use is found in in vitro data for the PPARα/γ agonism testing and in vivo data for the effect of the compounds on the rat model of hyperlipidemia induced by high cholesterol diet, the effect of 7-day oral gavage on the body weights of ICR mice, etc. on pages 73-86 of the specification.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic effects of any condition mediated by PPARα and/or γ receptor activity, whether or not the condition is effected by the activity at PPAR α and/or γ receptors would make a difference.
For example, Applicants claims are drawn to a method for preventing diabetes. Diabetes, also known as diabetes mellitus, is defined as impaired insulin secretion and variable degrees of peripheral insulin resistance leading to hyperglycemia. Early symptoms are related to hyperglycemia and include polydipsia, polyphagia and polyuria. Later complications include vascular disease, peripheral neuropathy and predisposition to infection. There are two main categories of diabetes mellitus-type 1 and type 2. Treatment involves control of hyperglycemia to improve symptoms and prevent complications while minimizing hypoglycemic episodes. Oral antihyperglycemic drugs are the primary treatment for type 2 diabetes mellitus. However, there are no treatments that definitely prevent the onset or progression of type 1 diabetes mellitus.
(See https://www.cdc.gov/diabetes/about/about-type-1-diabetes.html).
The amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is minimal with regards to the prophylaxis of any diseases. There are no working examples present for the prevention of any of the diseases listed in the claims.
Test assays and procedure are provided in the specification for in vitro data for the PPARα/γ agonism testing and in vivo data for the effect of the compounds on the rat model of hyperlipidemia induced by high cholesterol diet, the effect of 7-day oral gavage on the body weights of ICR mice, etc. on pages 73-86. Receptor activity is generally unpredictable and the data provided is insufficient for one of ordinary skill in the art in order to extrapolate to the other compounds of the claims. It is inconceivable as to how the claimed compounds can treat the extremely difficult diseases embraced by the instant claims.
Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use of the instant compounds. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The breadth of the claims
The breadth of the claims is a method for the treatment and/or prophylaxis of diseases which are modulated by PPARα and/or PPAR γ agonists.
The quantity of experimentation needed and the level of the skill in the art
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases would be benefited by the effects of PPAR α and/or γ and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment of the diseases.
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compound encompassed in the instant claims, with no assurance of success.
This rejection can be overcome, for example, by deleting the term “prophylaxis” in the rejected claims.
V. Objections
Claim Objections
Claims 1, 3, 5, 6, 16, 20, 24, 27, 29, 32, 36, 38-40, 42, 44, 46, 52, 59 and 60 are objected to because of the following informalities: the claims contain the limitation “or its pharmaceutical acceptable salt” which should read “or a pharmaceutical acceptable salt thereof”. Appropriate correction is required.
VI. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
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